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Assessment of the Implementation of the ResQGARD® Impedance Threshold Device by the San Antonio Fire Department

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ClinicalTrials.gov Identifier: NCT01780350
Recruitment Status : Completed
First Posted : January 31, 2013
Results First Posted : February 27, 2015
Last Update Posted : February 27, 2015
Sponsor:
Information provided by (Responsible Party):
Advanced Circulatory Systems

Brief Summary:
This study is attached to a comprehensive quality assurance/quality improvement (QA/QI) program conducted by the Office of the medical director, and is designed to contribute to generalizable knowledge to determine effectiveness and tolerability of an FDA approved Impedance Threshold Device (ITD) device in a large urban emergency medical service (EMS) system. The cohort will comprise a convenience sample of patients that are being treated by EMS for a hypotensive emergency.

Condition or disease Intervention/treatment Phase
Acute Hypotension Device: ResQGARD ITD Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ResQGARD ITD
Subjects receive a ResQGARD ITD.
Device: ResQGARD ITD
Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel.



Primary Outcome Measures :
  1. Change in Systolic Blood Pressure From Baseline (Before ITD Use) [ Time Frame: During device use, up to 1 hour ]
    Determining whether the application of an ITD will provide improvement in systolic blood pressure in subjects with hypotension in patients being treated by San Antonio EMS when compared to baseline.


Secondary Outcome Measures :
  1. Tolerability [ Time Frame: Duration of device use, up to 1 hour ]
    Determine patient tolerability of the device while breathing through it. This is subjectively measured by the paramedic administering the device based on verbal reporting from the patient and paramedic estimation of the patient response to the device.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults between the ages of 18-120 years
  • presenting to EMS with or development of Hypotension during EMS interaction
  • treated by EMS with the ITD

Exclusion Criteria:

  • pediatric patients
  • patients that do not present with or develop hypotension
  • patients who the ITD will not form a secure seal due to anatomical abnormalities

Responsible Party: Advanced Circulatory Systems
ClinicalTrials.gov Identifier: NCT01780350     History of Changes
Other Study ID Numbers: W81XWH-BAA-11-1
First Posted: January 31, 2013    Key Record Dates
Results First Posted: February 27, 2015
Last Update Posted: February 27, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases